A randomized controlled trial of oral nutritional supplementation versus standard diet following McKeown minimally invasive esophagectomy in patients with esophageal malignancy: a pilot study

Abstract Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (RR 0.39, 95%CI 0.22–0.65). Severe complications (Clavien-Dindo ≥3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE (RR 0.49, 95%CI 0.25–0.88). Conclusion This study provides evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer.

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The first randomized controlled trial on early versus late oral feeding after minimally invasive esophagectomy and the ongoing quest for more evidence

Journal of Thoracic Disease ◽

10.21037/jtd.2017.09.72 ◽

2017 ◽

Vol 9 (10) ◽

pp. 3635-3637

Author(s):

Miguel A. Cuesta

Keyword(s):

Randomized Controlled Trial ◽

Minimally Invasive ◽

Controlled Trial ◽

Minimally Invasive Esophagectomy ◽

Oral Feeding ◽

Invasive Esophagectomy ◽

Randomized Controlled

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Intrathoracic versus cervical anastomosis after minimally invasive esophagectomy for esophageal cancer: A randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4509 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4509-4509

Author(s):

Moniek Verstegen ◽

Frans van Workum ◽

Bastiaan Klarenbeek ◽

Suzanne Gisbertz ◽

Gerjon Hannink ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Length Of Stay ◽

Minimally Invasive ◽

Controlled Trial ◽

Minimally Invasive Esophagectomy ◽

Secondary Outcome ◽

Ivor Lewis ◽

Invasive Esophagectomy ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

4509 Background: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods: In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results: A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded from the trial due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (relative risk 0.39, 95% CI 0.22-0.65; risk difference 19.4%, 95% CI 7.9%-31.8%). Overall AL rate was 12.3% after Ivor Lewis MIE and 34.1% after McKeown MIE. Severe complications (Clavien-Dindo ≥ 3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE. Pleural effusion requiring drainage occurred in 9.8% of patients after Ivor Lewis MIE and 21.1% of patients after McKeown MIE. RLN palsy rate was 0% after Ivor Lewis MIE and 7.3% after McKeown MIE. Median length of hospital stay was 10 days (IQR 8 – 15 days) after Ivor Lewis MIE and 12 days (IQR 9 – 18 days) after McKeown MIE. ICU length of stay and mortality rates were comparable between groups. Conclusions: These findings provide evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer. Clinical trial information: NTR4333 .

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